Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020095
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZANTAC 150 RANITIDINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
ZANTAC 300 RANITIDINE HYDROCHLORIDE EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/08/1994 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/2002 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18703s61ltr.pdf
05/09/2001 SUPPL-12 Labeling

Label is not available on this site.

10/29/1999 SUPPL-11 Labeling

Label is not available on this site.

10/22/1999 SUPPL-10 Labeling

Label is not available on this site.

10/22/1999 SUPPL-9 Labeling

Label is not available on this site.

09/12/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/29/1999 SUPPL-7 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20095S7_zantacgelcapsules_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20095S7_zantacgelcapsules.cfm
11/27/1996 SUPPL-6 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20251S6_zantecefferdose.cfm
03/29/1995 SUPPL-5 Labeling

Label is not available on this site.

11/14/1994 SUPPL-4 Labeling

Label is not available on this site.

11/03/1994 SUPPL-2 Labeling

Label is not available on this site.

04/04/1994 SUPPL-1 Labeling

Label is not available on this site.

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